Patient Experience Study of Deoxycholic Acid Injection

Moderate or Severe Submental Fullness Clinical Trial

Official title: A Single Center, Double-blind, Parallel-group, Two Factor Patient-Experience Management Study of ATX-101 (Deoxycholic Acid Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

Status Completed

Clinical Trial Summary

The objectives of this study are to determine the safety of deoxycholic acid subcutaneous (SC) injections in the submental area and to evaluate the effects of four interventions, relative to placebo in the submental area, particularly with regard to assessment and management of pain, bruising, and swelling/edema.

Clinical Trial Description

This study evaluated the effects of four interventions, pre- and post-subcutaneous injections of deoxycholic acid injection relative to placebo in adults with submental fullness. Participants were randomized to either deoxycholic acid injection or placebo in a ratio of 4:1 and to one of four patient experience management paradigms.

Participants were required to visit the research facility on 10 separate occasions for protocol-defined treatments, procedures, tests, and observations. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Moderate or Severe Submental Fullness

• NCT number: NCT02007434
• Study type: Interventional
• Source: Kythera Biopharmaceuticals
• Status: Completed
• Phase: Phase 3
• Start date: December 2013
• Completion date: June 2014